Sight Sciences Publishes 24-Month SAHARA RCT Results Evaluating TearCare in Dry Eye Disease
Sight Sciences has published 24-month results from Stage 3 of its landmark SAHARA randomized controlled trial (RCT).
The study, published in Optometry and Vision Science, assesses the long-term efficacy and retreatment interval of the TearCare System, confirming statistically and clinically significant improvements in both signs and symptoms of dry eye disease (DED) sustained over a 2-year period—often with just one or two treatments.
Among 166 participants treated with TearCare at baseline and again at Month 5:
66% required no additional treatment for the rest of the 24-month study duration
Only 7% required a third or fourth treatment
The median time to retreatment was 7 months
The 6-month retreatment-free survival probability stood at 92%
“These results demonstrate the durability, repeatability, and significant clinical benefits of treatment with TearCare in a landmark device versus drug RCT,” said Paul Badawi, Co-Founder and Chief Executive Officer of Sight Sciences. “This 24-month endpoint adds to the successful clinical trial results from the previous two stages of the SAHARA trial as well as numerous other studies, expanding a robust body of research evidencing both the effectiveness and durability of interventional dry eye therapy with TearCare. We were pleased to see the 24-month SAHARA RCT data confirm that participants achieved and maintained clinically significant improvements in all signs and symptoms of dry eye disease with one to two TearCare treatments per year.”
Clinical Metrics at 24 Months: Significant and Sustained
Tear Break-Up Time (TBUT) improved from a baseline of 4.41 seconds to 6.29–7.13 seconds at all follow-up timepoints (P<.0001).
Meibomian Gland Secretion Score (MGSS) rose from 7.26 to ~18.9, and remained consistent across 24 months (P<.0001).
MGYAL, MGYCL, conjunctival/corneal staining, and Schirmer tear scores (STS) all demonstrated sustained improvements through Month 24
Subjective symptom scores using OSDI, SANDE, and EDS stayed near the levels achieved at Month 6 and significantly better than baseline at all follow-ups:
OSDI: 50.3 → 31.9
SANDE: 66.8 → 40.2
EDS: 65.1 → 39.9
(All P<.0001)
Trial Design: A Device vs. Drug Benchmark
According to Sight Sciences, the SAHARA RCT stands out for its size and rigor:
Stage 1: Compared TearCare vs. twice-daily Restasis. TearCare was superior in improving Tear breakup time (TBUT)—the trial’s primary endpoint
Stage 2: Former Restasis users were crossed over to TearCare at Month 6. After a single TearCare treatment and stopping Restasis, they achieved additional significant improvements in signs and symptoms
Stage 3: Focused on durability and optimal retreatment intervals, tracking participants up to Month 24
Retreatment was allowed based on objective signs (TBUT within 2 seconds of baseline) and subjective symptoms (OSDI increase ≥15 points)